依诺肝素钠相对分子量的EP与USP分析方法对比研究

Comparative study on relative molecular weight analysis of Enoxaparin Sodium by EP and USP methods

目的以国产依诺肝素钠和其原研药为样品,比较欧洲药典(EP)和美国药典(USP)测定依诺肝素钠相对分子质量(Mr)方法的差异,为国内该品种的药典标准制定提供参考。方法采用这两种方法分别检测了10批国产依诺肝素钠原料药和2批原研药注射液LOVENOX的Mr情况。结果 USP方法测得平均Mr均较EP方法结果偏高在200以内,Mr2 000以下组分比例EP方法偏高,而Mr2 000～8 000组分比例USP方法偏高,但差距均在4%以内。国产依诺肝素钠Mr与原研药的基本一致。结论 EP和USP方法分析依诺肝素钠Mr结果较为接近。

Purpose To analyze the difference of the relative molecular weight（M,） analysis method of Enoxaparin Sodium in european Pharmacopoeia （EP）and the United States Pharmacopoeia （USP） through the analysis of domestic samples and the branded, and to provide some opinions for Enoxaparin Sodium domestic standard. Methods Ten batches of Enoxaparin Sodium samples and 2 batches brand In-jection Lovenox Enoxaparin Sodium were analyzed in EP and USP method. Results The average Mr by EP method was higher than that by USP method with difference of less than 200. The percentage of less than 2 000 by EP method was higher,and that of 2 000 - 8 000 by USP method was higher and both differ- ences within 4%. The Mr of domestic samples was comparable to the branded. Conclusion Tile results of M of Enoxaparin Sodium by EP method were closed to those by USP method.